The invention pertains to methods of determining the presence of periodontal disease in mammals, and more particularly to methods of determining active periodontal disease by assaying for the presence of elevated levels of the enzyme aspartate aminotransferase.
Periodontal diseases are inflammatory diseases of microbial etiology affecting the supporting tissues of the teeth. These diseases, which affect over 70% of the adult population, are the leading causes of tooth loss in people over 35 years of age. Costs associated with periodontal disease, including cost of treatment and the economic cost due to loss of productivity, are extremely high. It was estimated in 1976 that the cost of effective management of all those suffering from periodontal disease (more than 100 million people) would be many times the 1.5 billion dollars spent at that time [see "Evaluation of NIDR Periodontal Disease Research Activity--Report of the Ad Hoc Scientific Evaluation Panel", National Institutes of Dental Research, Washington, D.C. (April 1976)].
The term "periodontal disease" encompasses two major subclasses of disease, gingivitis and periodontitis. "Gingivitis" is characterized by inflammation of the gums in the absence of bone and attachment loss. See Loe, H. and P. Silness, Acta Odont. Scand. 21:533 (1963). "Periodontitis" is generally accepted to be an advanced stage of gingivitis, further characterized by formation of periodontal pockets between the gum tissue and tooth, followed by loss of bone from the tooth and weakening of tooth attachment, eventually leading to tooth loss. See Ramfjord, S., J. Periodontol. 38:602 (1967). Periodontitis may be further classified, e.g. juvenile periodontitis, local periodontitis, acute necrotizing periodontitis, chronic inflammatory periodontitis (CIPD). CIPD is the most common form of periodontitis among American adults and is characterized by loss of attachment of periodontal ligament to cementum, apical migration of junctional epithelium, and loss of alveolar bone. Both gingivitis and periodontitis are characterized by accumulation of crevicular fluid (a transudate of serum) at the junction of the teeth and gums.
Although periodontal disease is one of the most prevalent bacterial diseases in the civilized world, no objective diagnostic assay is available. In its early stages the disease may be asymptomatic; it is also frequently episodic, with a cyclical pattern of destructive activity interspersed with periods of latency or spontaneous partial regression. Presently available methods of measuring periodontal disease include subjective observational indices such as those of Loe, H. and P. Silness, Acta Odont. Scand. 21:533 (1963) for gingivitis and Ramfjord, S., J. Periodontol. 38:602 (1967) for periodontitis. These indices are based on criteria such as bleeding on gentle probing, pocket depth, attachment loss, and radiographic evidence of bone loss. Unfortunately, these clinical indicators, with the exception of bleeding on probing, are generally acknowledged to be reflective of past disease and prior damage. Of these indicators, only bleeding on probing (bleeding of gum tissue due to probing of the gum line or pocket with a hard instrument, e.g. probe or curet) has been claimed to correlate with active periodontal disease. However, recently the diagnostic value of bleeding on probing has been questioned. See Haffajee, A. D., S. S. Socransky, and J. M. Goodson, J. Clin. Perio. 10:257-265 (1983).
It is a purpose of this invention to provide an objective assay for the determination of the presence of active periodontal disease.
It is further a purpose to provide an objective assay for the presence of active periodontal disease, which assay is rapid, simple, and non-invasive.
It is another purpose of this invention to provide a kit for an objective assay to determine the presence of active periodontal disease, for use by clinicians.
It is yet another purpose of this invention to provide a kit for a simple, rapid, objective assay to determine the presence of active periodontal disease, for home use by the patient.